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NKT2152 Shows Promise in Advanced Renal Cell Carcinoma

• NKT2152, a novel oral HIF2α inhibitor, demonstrates encouraging objective response rates (ORR) in pretreated advanced clear cell renal cell carcinoma (RCC) patients. • The phase 1/2 study (NCT05119335) involving 100 RCC patients presented at the 2024 ESMO Congress, highlights NKT2152's robust antitumor activity. • FDA has approved trastuzumab-strf (Hercessi) 420-mg dose for HER2-overexpressing cancers, expanding access to this biosimilar following the 150-mg approval. • Amivantamab plus chemotherapy gains FDA approval for EGFR-mutated NSCLC post-TKI treatment based on the MARIPOSA-2 trial results.

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

NCT04739761Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/22/2021

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

NCT04987203Active, Not RecruitingPhase 3
AVEO Pharmaceuticals, Inc.
Posted 9/9/2021

Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

NCT03084237CompletedPhase 3
Shanghai Henlius Biotech
Posted 11/1/2016

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

NCT04685135Active, Not RecruitingPhase 3
Mirati Therapeutics Inc.
Posted 2/23/2021

A Study of NKT2152, a HIF2α Inhibitor, in Patients with Advanced Clear Cell Renal Cell Carcinoma

NCT05119335Active, Not RecruitingPhase 1
NiKang Therapeutics, Inc.
Posted 10/26/2021

AriBio's AR1001 Phase 3 Trial for Early Alzheimer's Enrolls First Patients

  • Adaptive Research has announced the enrollment of the first patients in AriBio's Phase 3 POLARIS-AD trial for AR1001.
  • The trial will assess the efficacy and safety of AR1001 in slowing the progression of early Alzheimer's disease over 52 weeks.
  • This global study aims to enroll 1150 participants, emphasizing the inclusion of diverse populations through community-based sites.
  • AR1001 previously completed a Phase 2 study in mild to moderate Alzheimer's, showing potential in treating the disease.

Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)

NCT05531526Active, Not RecruitingPhase 3
AriBio Co., Ltd.
Posted 12/23/2022

Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

NCT03625622CompletedPhase 2
AriBio Co., Ltd.
Posted 4/1/2019

FDA Clears IND for Calidi Biotherapeutics' CLD-101 in High-Grade Glioma

  • The FDA has cleared Northwestern University's IND application for Calidi Biotherapeutics' CLD-101, a stem cell-based oncolytic virus therapy.
  • A Phase 1b/2 trial will evaluate multiple doses of CLD-101 in patients with newly diagnosed high-grade glioma, commencing in late 2024.
  • Prior Phase 1 study showed CLD-101 was safe and feasible, with promising progression-free and overall survival results in glioma patients.
  • CLD-101 is also in Phase 1 trials for recurrent high-grade glioma, with interim data expected in H1 2025.

NeuroBo's DA-1726 Shows Positive Safety and Tolerability in Phase 1 Obesity Trial

  • NeuroBo Pharmaceuticals announced positive top-line data from the Phase 1 clinical trial of DA-1726 for obesity.
  • The single ascending dose (SAD) study demonstrated favorable safety, tolerability, and dose-linear pharmacokinetics.
  • DA-1726 is a novel dual agonist of GLP-1 and glucagon receptors, potentially offering improved tolerability over existing GLP-1 agonists.
  • Top-line data from the multiple ascending dose (MAD) Part 2 study is expected in the first quarter of 2025.

First in Human Study in Subjects With Obesity, But Otherwise Healthy

NCT06252220RecruitingPhase 1
NeuroBo Pharmaceuticals Inc.
Posted 3/25/2024

Family Heart Foundation Launches Free At-Home Lipid Screening Program to Combat Cardiovascular Disease

  • The Family Heart Foundation has introduced Cholesterol Connect, offering free at-home lipid screening and personalized support to address cardiovascular disease, which claims one American life every 33 seconds.
  • The program, sponsored by Amgen, provides comprehensive testing for total cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a), with 71 million Americans having high LDL-C but 40% unaware of their condition.
  • Participants receive access to virtual consultations with Care Navigators, educational resources, and secure result sharing capabilities, regardless of insurance status.

Dana-Farber Cancer Institute Completes Record-Breaking $2.5 Billion Fundraising Campaign

  • Dana-Farber Cancer Institute concluded a seven-year fundraising campaign, raising a record $2.5 billion to advance cancer research and patient care.
  • The funds will support clinical trials, enhance cancer care equity programs, and facilitate the expansion of medical facilities to improve patient access.
  • A new integrated clinic was launched to focus on early detection and prevention of cancer in high-risk individuals, utilizing novel technologies.
  • The campaign enabled a 26% increase in patients served since 2019, with over 96,000 patients receiving care in the past year alone.

GenEditBio Secures Investment to Advance Genome Editing Technologies

  • GenEditBio has received strategic investment from Gobi Partners GBA to accelerate the development of its genome editing technologies.
  • The funding will support the advancement of GenEditBio's in vivo programs and the initiation of clinical studies for safety and efficacy.
  • GenEditBio's GEB-400 program, targeting an inherited retinal disease, is expected to enter the clinical stage in 2025.
  • The company focuses on providing affordable "precision DNA surgery" for genetic diseases with unmet needs.

BridgeBio's BBP-418 Completes Enrollment in Phase 3 Trial for LGMD2I/R9

  • BridgeBio Pharma has completed enrollment for its Phase 3 FORTIFY study evaluating BBP-418 in Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9).
  • The study exceeded its target enrollment, and topline data from the interim analysis are expected in 2025, offering hope for a potential accelerated approval.
  • BBP-418 could be the first approved therapy for LGMD2I/R9 in the U.S., addressing a significant unmet need for patients with this progressive muscle-wasting condition.
  • The FDA has granted BBP-418 Orphan Drug, Fast Track, and Rare Pediatric Disease Designations, potentially expediting the regulatory process.

Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

NCT05775848Active, Not RecruitingPhase 3
ML Bio Solutions, Inc.
Posted 5/31/2023

Biomarker Development in LGMD2i

NCT04202627Completed
ML Bio Solutions, Inc.
Posted 12/1/2019

Study of BBP-418 in Patients With LGMD2I

NCT04800874Active, Not RecruitingPhase 2
ML Bio Solutions, Inc.
Posted 2/18/2021

Biohaven Launches Phase 2 Trial of TRPM3 Antagonist BHV-2100 for Acute Migraine Treatment

  • Biohaven has initiated a Phase 2 clinical trial to evaluate BHV-2100, a novel, orally administered TRPM3 antagonist, for the acute treatment of migraine.
  • The trial is a randomized, double-blind, placebo-controlled study assessing the efficacy and safety of two BHV-2100 doses (75 mg and 150 mg) in approximately 575 patients.
  • BHV-2100 demonstrated a favorable safety profile in Phase 1 trials and targets the TRPM3 ion channel, which has been implicated in migraine pathophysiology.
  • The study's primary endpoints are pain freedom and freedom from the most bothersome symptom at 2 hours, with additional secondary endpoints to assess sustained relief and functionality.

Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine

NCT06603623Active, Not RecruitingPhase 2
Biohaven Therapeutics Ltd.
Posted 10/10/2024

NIH Study Finds No Reliable Biomarkers for Long COVID Using Routine Clinical Tests

  • A recent NIH study found that standard clinical laboratory tests do not provide reliable biomarkers for diagnosing Long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC).
  • The RECOVER Initiative analyzed over 10,000 individuals with and without prior COVID-19 diagnoses, but failed to identify a consistent biomarker across 25 common lab tests.
  • Researchers highlight the inconsistent definition of PASC as a major challenge, hindering the identification of reliable biomarkers for diagnosis and treatment design.
  • Future research should focus on advanced techniques like transcriptomics and proteomics to discover novel biomarkers for accurate and rapid diagnosis of Long COVID.

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